Intellipharmaceutics Update on its Oxycodone ER New Drug Application
Download as PDFOctober 24, 2019
TORONTO, ON / ACCESSWIRE / October 24, 2019 / Intellipharmaceutics International Inc. (OTCQB:IPCIF and TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced today that it has been advised by the U.S. Food and Drug Administration ("FDA") that product specific advisory committee meetings for opioid analgesics, as related to Intellipharmaceutics' Oxycodone ER New Drug Application ("NDA"), which were previously postponed, as announced on July 24, 2019, are no longer on hold. The Company is pleased with this development and is prepared to attend any advisory committee meetings in the future.
We anticipate that the FDA will take action regarding approvability or otherwise, on our application, after the advisory committee meeting is held for Intellipharmaceutics' Oxycodone ER NDA. However there can be no assurance of the timing of an action being taken, as there are many factors that may affect when the FDA may take action.
There can be no assurance that an advisory committee meeting to discuss our NDA will take place in the foreseeable future or at all. There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's abuse-deterrent oxycodone hydrochloride extended release formulation ("Oxycodone ER") based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-
